Regulatory Updates
Resolución 01-2014 de la Comisión Nacional de Registro y Control de Sustancias Tóxicas (Resolution No. 01-2014 of the National Commission for the Registration and Control of Toxic Substances)
Distribution date: 31 March 2014
Mechanism for the regulation and control of hazardous toxic substances; cancellation of the registration of certain substances.The notified text establishes a period of one (1) year from the entry into force of the Resolution during which any remaining stocks of these molecules may be marketed in the country.It also establishes import and marketing controls for paraquat-based products containing the following health protection agents: emetics, colourant and odorant. During the marketing of the products, records shall be kept of the quantities sold, the buyers of the products, and the crops on which the products will be used.The text bans the free marketing and storage of aluminium phosphide and the registration, importation, marketing and use of brodifacoum, bromadiolone and flocoumafen in powder form.
Products Covered: Toxic substances (molecules of carbofuran, aldicarb, endosulfan, terbufos, methomyl, ethoprophos, paraquat, chlorpyrifos, aluminium phosphide, brodifacoum, bromadiolone, and flocoumafen).
Regulation Type: Regular notification
<p><span style="text-decoration:underline;">Notice of Intent to Amend the Prescription Drug List (PDL): Omeprazole</span></p><p></p><p>The proposed amendment notified in G/TBT/N/CAN/401 (dated 13 November 2013) was adopted 17 March 2014.</p><p></p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for omeprazole on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of omeprazole against a set of established and publicly available criteria outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p></p><p>This revision will be in effect six months from the date of this Notice posted on the Health Canada website.</p><p></p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php</a> (English)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php</a> (French)</span></span></p><p></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>or requested from:</span></span></span></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Canadian Enquiry Point<br />Standards Council of Canada<br />200-270 Albert Street<br />Ottawa, Ontario<br />K1P 6N7<br />Tel.: (613) 238-3222<br />Fax: (613) 569-7808<br />E-mail: <a href="mailto:[email protected]"><span style="color:blue;"><span style="color:blue;">[email protected]</span></span></a></span></span></span></p><p></p><p></p><p></p><p></p><p><span style="text-decoration:underline;"></span></p>http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php
Distribution date: 28 March 2014
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
<p><span style="text-decoration:underline;">Notice of Intent to Amend the Prescription Drug List (PDL): Omeprazole</span></p><p></p><p>The proposed amendment notified in G/TBT/N/CAN/401 (dated 13 November 2013) was adopted 17 March 2014.</p><p></p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for omeprazole on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of omeprazole against a set of established and publicly available criteria outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p></p><p>This revision will be in effect six months from the date of this Notice posted on the Health Canada website.</p><p></p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php</a> (English)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php</a> (French)</span></span></p><p></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>or requested from:</span></span></span></p><p align="left" style="text-align:left;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Canadian Enquiry Point<br />Standards Council of Canada<br />200-270 Albert Street<br />Ottawa, Ontario<br />K1P 6N7<br />Tel.: (613) 238-3222<br />Fax: (613) 569-7808<br />E-mail: <a href="mailto:[email protected]"><span style="color:blue;"><span style="color:blue;">[email protected]</span></span></a></span></span></span></p><p></p><p></p><p></p><p></p><p><span style="text-decoration:underline;"></span></p>http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-eng.php http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_omeprazole-fra.php
Distribution date: 28 March 2014
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
Notice of Consultation- Prescription Drug List (PDL): Triamcinolone acetonide (2 pages, in English and French) .
Distribution date: 28 March 2014 | Final date for Comment: 27 May 2014
<p>The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL). </p>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation- Prescription Drug List (PDL): Triamcinolone acetonide (2 pages, in English and French) .
Distribution date: 28 March 2014 | Final date for Comment: 27 May 2014
<p>The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL). </p>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
<p><a name="spsTitle"><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Mandatory Implementation of Indonesia National Standard for Zinc Oxide notified under G/TBT/N/IDN/</span></span></span></span></a><span><span style="text-decoration:underline;"><span lang="IN">72 </span></span></span><span><span style="text-decoration:underline;"><span lang="EN-GB">dated 2</span></span></span><span><span style="text-decoration:underline;"><span lang="IN">4</span></span></span><span><span style="text-decoration:underline;"><span lang="IN"></span></span></span><span><span style="text-decoration:underline;"><span lang="IN">April</span></span></span><span><span style="text-decoration:underline;"><span lang="EN-GB">201</span></span></span><span style="text-decoration:underline;"><span lang="IN">3</span></span></p><p style="margin-bottom:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Addendum of mandatory implementation of Indonesia National Standard for</span></span></span><span lang="EN-GB"> </span><span lang="EN-GB" style="letter-spacing:-0.1pt;">Zinc Oxide</span><span lang="IN" style="letter-spacing:-0.1pt;"> (SNI 0085:2009). </span></p><p style="margin-bottom:6pt;"><span lang="IN" style="letter-spacing:-0.1pt;"></span><span lang="EN-GB">The draft of this regulation has been stipulated through "Regulation of Minister of Industry No. </span><span lang="IN">66</span><span lang="EN-GB">/M-IND/PER/</span><span lang="IN">11</span><span lang="EN-GB">/2013" and will be coming into force on </span><span lang="IN">6</span><span lang="EN-GB"> (</span><span lang="IN">six</span><span lang="EN-GB">) months after promulgation. </span></p><p align="left" style="text-align:left;margin-bottom:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>The text is available from:</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Centre for Cooperation on Standardization</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>National Standardization Agency, Indonesia (BSN)</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Manggala Wanabakti Bld, Block IV, 4th floor</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Jl. Jend. Gatot Subroto, Senayan</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Jakarta 10270</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Indonesia</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Telephone:<span> </span>+(6221) 5747043 ext. 117/262, 5747044</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Facsimile: +(6221) 5747045</span></span></span></p><p align="left" style="text-align:left;"><span style="font-face:Verdana;font-size:x-small;"><span style="font-size:9pt;"><a href="http://members.wto.org/crnattachments/2014/tbt/IDN/14_1595_00_x.pdf"><span>http://members.wto.org/crnattachments/2014/tbt/IDN/14_1595_00_x.pdf</span></a></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">E-mail:<span> </span><a href="mailto:[email protected]">[email protected]</a>; <a href="mailto:[email protected]">[email protected]</a></span></span></p>
Distribution date: 28 March 2014
Products Covered: HS. 2817.00.10.00
Regulation Type: Addendum to Regular Notification
<p><a name="spsTitle"><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Mandatory Implementation of Indonesia National Standard for Zinc Oxide notified under G/TBT/N/IDN/</span></span></span></span></a><span><span style="text-decoration:underline;"><span lang="IN">72 </span></span></span><span><span style="text-decoration:underline;"><span lang="EN-GB">dated 2</span></span></span><span><span style="text-decoration:underline;"><span lang="IN">4</span></span></span><span><span style="text-decoration:underline;"><span lang="IN"></span></span></span><span><span style="text-decoration:underline;"><span lang="IN">April</span></span></span><span><span style="text-decoration:underline;"><span lang="EN-GB">201</span></span></span><span style="text-decoration:underline;"><span lang="IN">3</span></span></p><p style="margin-bottom:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Addendum of mandatory implementation of Indonesia National Standard for</span></span></span><span lang="EN-GB"> </span><span lang="EN-GB" style="letter-spacing:-0.1pt;">Zinc Oxide</span><span lang="IN" style="letter-spacing:-0.1pt;"> (SNI 0085:2009). </span></p><p style="margin-bottom:6pt;"><span lang="IN" style="letter-spacing:-0.1pt;"></span><span lang="EN-GB">The draft of this regulation has been stipulated through "Regulation of Minister of Industry No. </span><span lang="IN">66</span><span lang="EN-GB">/M-IND/PER/</span><span lang="IN">11</span><span lang="EN-GB">/2013" and will be coming into force on </span><span lang="IN">6</span><span lang="EN-GB"> (</span><span lang="IN">six</span><span lang="EN-GB">) months after promulgation. </span></p><p align="left" style="text-align:left;margin-bottom:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>The text is available from:</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Centre for Cooperation on Standardization</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>National Standardization Agency, Indonesia (BSN)</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Manggala Wanabakti Bld, Block IV, 4th floor</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Jl. Jend. Gatot Subroto, Senayan</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Jakarta 10270</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Indonesia</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Telephone:<span> </span>+(6221) 5747043 ext. 117/262, 5747044</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Facsimile: +(6221) 5747045</span></span></span></p><p align="left" style="text-align:left;"><span style="font-face:Verdana;font-size:x-small;"><span style="font-size:9pt;"><a href="http://members.wto.org/crnattachments/2014/tbt/IDN/14_1595_00_x.pdf"><span>http://members.wto.org/crnattachments/2014/tbt/IDN/14_1595_00_x.pdf</span></a></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">E-mail:<span> </span><a href="mailto:[email protected]">[email protected]</a>; <a href="mailto:[email protected]">[email protected]</a></span></span></p>
Distribution date: 28 March 2014
Products Covered: HS. 2817.00.10.00
Regulation Type: Addendum to Regular Notification
Draft resolution regarding the active ingredient TRANSFLUTRINA of the monograph list of active ingredients for pesticides, household cleaning products and wood preservers, published by Resolution - RE n° 165 of 29 August 2003, Brazilian Official Gazette (DOU Diário Oficial da União) of 2 September 2003
Distribution date: 24 March 2014 | Final date for Comment: 12 April 2014
Draft resolution regarding the active ingredient TRANSFLUTRINA of the monograph list of active ingredients of pesticides, household cleaning products and wood preservers. This resolution proposes to increase the maximum allowed concentration from 280 to 330 mg/each for use in household cleaning products: Sale to the general public: liquids and aerosols (maximum allowed concentration: 0.6% p/p); liquid repellent (maximum allowed concentration: 0.88% p/p); repellent tablets and strips (maximum allowed concentration: 15mg/each); spirals (maximum allowed concentration: 0.06% p/p); anti moth paper (maximum allowed concentration: 1.0% g/m2); gel repellents (maximum allowed concentration: 39.5% p/p); long lasting repellents, tablets and discs (maximum allowed concentration: 330 mg/each). (*) Label or package leaflet must contain the following wording: Do not use in poorly ventilated environment, especially in the presence of children. This product cannot be used by asthmatic persons, with respiratory problems or allergic to pyrethroids.
Products Covered: Insecticides: sale to the general public: liquids and aerosols (maximum allowed concentration: 0.6% p/p); liquid repellent (maximum allowed concentration: 0.88% p/p); repellent tablets and strips (maximum allowed concentration: 15mg/each); spirals (maximum allowed concentration: 0.06% p/p); anti moth paper (maximum allowed concentration: 1.0% g/m2); gel repellents (maximum allowed concentration: 39.5% p/p); long lasting repellents, tablets and discs (maximum allowed concentration: 330 mg/each). (*) Label or package leaflet must contain the following wording: Do not use in poorly ventilated environment, especially in the presence of children. This product cannot be used by asthmatic persons, with respiratory problems or allergic to pyrethroids.
Regulation Type: Regular notification
Draft resolution regarding the active ingredient TRANSFLUTRINA of the monograph list of active ingredients for pesticides, household cleaning products and wood preservers, published by Resolution - RE n° 165 of 29 August 2003, Brazilian Official Gazette (DOU Diário Oficial da União) of 2 September 2003
Distribution date: 24 March 2014 | Final date for Comment: 12 April 2014
Draft resolution regarding the active ingredient TRANSFLUTRINA of the monograph list of active ingredients of pesticides, household cleaning products and wood preservers. This resolution proposes to increase the maximum allowed concentration from 280 to 330 mg/each for use in household cleaning products: Sale to the general public: liquids and aerosols (maximum allowed concentration: 0.6% p/p); liquid repellent (maximum allowed concentration: 0.88% p/p); repellent tablets and strips (maximum allowed concentration: 15mg/each); spirals (maximum allowed concentration: 0.06% p/p); anti moth paper (maximum allowed concentration: 1.0% g/m2); gel repellents (maximum allowed concentration: 39.5% p/p); long lasting repellents, tablets and discs (maximum allowed concentration: 330 mg/each). (*) Label or package leaflet must contain the following wording: Do not use in poorly ventilated environment, especially in the presence of children. This product cannot be used by asthmatic persons, with respiratory problems or allergic to pyrethroids.
Products Covered: Insecticides: sale to the general public: liquids and aerosols (maximum allowed concentration: 0.6% p/p); liquid repellent (maximum allowed concentration: 0.88% p/p); repellent tablets and strips (maximum allowed concentration: 15mg/each); spirals (maximum allowed concentration: 0.06% p/p); anti moth paper (maximum allowed concentration: 1.0% g/m2); gel repellents (maximum allowed concentration: 39.5% p/p); long lasting repellents, tablets and discs (maximum allowed concentration: 330 mg/each). (*) Label or package leaflet must contain the following wording: Do not use in poorly ventilated environment, especially in the presence of children. This product cannot be used by asthmatic persons, with respiratory problems or allergic to pyrethroids.
Regulation Type: Regular notification
Draft Thai Industrial Standard for Alkyd Enamel: Safety Requirement (TIS 2625-25xx) (7 pages, in Thai)
Distribution date: 24 March 2014 | Final date for Comment: 23 May 2014
<span style="font-size:x-small;font-face:Verdana;"><span style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">The Thai Industrial Standards Institute (TISI) has proposed to enforce TIS 2625-25xx </span><span style="font-size:x-small;"><span style="font-size:9pt;">Alkyd enamel: safety requirement<span style="letter-spacing:-0.1pt;"> as </span>a mandatory standard. <span> </span>This draft standard </span><span style="font-size:x-small;"><span style="font-size:9pt;">covers only </span><span style="font-size:x-small;"><span style="font-size:9pt;">alkyd enamel (gross, semi gloss and flat)</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">for </span><span style="font-size:x-small;"><span lang="EN-US" style="background:white;font-size:9pt;">top coat</span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">paint, and quantitative safety of </span><em><em><span style="font-size:x-small;font-face:Verdana;"><span style="background:white;font-family:'Verdana','sans-serif';font-size:9pt;">toxic heavy metals</span></span></em></em><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">.<span> </span>It specifies<span style="letter-spacing:-0.1pt;"> types, materials, requirements, </span></span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">packaging, marking and labeling, sampling and criteria for conformity, and testing.</span></span></span></span></span></span></span></span></span></span>
Products Covered: Paints and varnishes (HS: 3209; ICS: 87.040)
Regulation Type: Regular notification
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